Research Contract and Budgets 101:

1. Research Contract and Budgets 101: How to Deal with Children’s & Emory and Keep your Sanity Clinical Research Department Office of Grants Accounting and Contracts

2. Administrative Grants and Contract Process • Purpose of Grants and Contract Process • Pre-award process • Feasibility Assessment and Ancillary Department Approval Form • Sponsor Budget • Patient Care Budgeting • Contract Process for Children’s • Subcontract Process between Emory and Children’s • Children’s Final Approval Process • Post –Award Process • Coordinating the Project • Patient Care Invoicing • Grants Accounting

3. Purpose of Grants and Contract Process • To insure that pre and post award processes are compliant with policies and regulations of: • Children’s Healthcare of Atlanta • Sponsor or Funding Agency • Local, state and federal regulations

4. PRE-AWARD PROCESS

5. Feasibility Assessment and Ancillary Department Approval Form • Purpose: • To provide an overall view of the project • Determine what patient care procedures are needed • Budgeting for patient care procedures: • Children’s Technical fees: billed by Children’s • Professional Fees: billed by provider • Review and approval by Ancillary Service • Standard of Care or Research Procedure? • Equipment? • Personnel? • To receive final project approval from Children’s • Effective August 1, 2006.

6. Review attached Feasibility Assessment and Ancillary Service Approval Form

7. Sponsor Budget • DIRECT COSTS: • Funds provided to cover the cost of conducting the study • Funds will be placed into a Grant Activity account • Considerations for direct costs • Principal Investigator Time • Coordinator Time • Patient Care Costs • Supplies and Travel • Administrative Time – indirects may or may not apply • IRB Submission Fees – indirects may or may not apply

8. Sponsor Budget con’t • INDIRECT COSTS • Established percentage rate applied to direct costs • Direct Costs + Indirect Costs = Total Project Budget • Used to support Children’s research infrastructure • CHILDREN’S ESTABLISHED RATES • Federal Government 42.6% (new agreement forthcoming) • Private Industry 20% • External Foundation: dependent on Foundation • Internal Foundation: none

9. Patient Care Budgeting • Request cost from Office of Grants Accounting and Contracts • Provide the following information: ▪Name of Project ▪PI Name ▪Coordinator Name ▪Funding Source ▪Procedures needed • Considerations for patient care procedures: • Endoscopy – GI Lab, Minor Procedure Room, or Operating Room • Brain MRI – Without Contrast, With Contrast, With and Without Contrast • Conscious Sedation Services needed? • Blood Draw –Lab, inpatient unit or clinic

10. Patient Care Budgeting – Con’t • Research Discounting is applied according to funding source • 40% discount for Private Industry/Foundations/Internal Funding • Federal funding based on Schedule C of Medicaid Cost Report • Budgets ARE NOT interchangeable between funding sources or projects • Prices are based on current hospital charges; changes at least once per year • You will be provided a written budget • Prices are quoted for the duration of the project • Budget remains on file until project is funded & the contract signed

11. Contract Process for Children’s • Beverly Yandell, Manger Grants Accounting and Contracts • Is the contact person for sponsor • Obtains Legal and Risk Management Department review • Resolves issues with Sponsor • Obtains signature from PI if applicable • Obtains signature from Children’s Institution Official and Sponsor • Provides original signed contract to Children’s Legal Department • Provides copy of contract to PI, Coordinator, Finance Dept. • Opens Grant Activity account with Children’s Finance Dept. • Provides NOTICE OF GRANT AWARD to PI and Finance Dept.

12. Subcontract Process between Emory and Children’s • Principal Investigator is Emory faculty and Emory administers funds • Children’s employees are listed as study staff • No Subcontract is necessary if only cost to Children’s is patient care procedures, this will be invoiced separately • Primary contract is between Sponsor and Emory • Emory subcontracts Children’s • Create separate Children’s internal budget (direct and indirect costs) • Complete Children’s Budget Approval Routing Sheet • Children’s Director of Research signs routing sheet • Original goes to Emory OSP, copy on file in Office of Grants Accounting • The Children’s internal budget becomes part of the Emory budget as a direct cost. • Signed Budget Approval Routing Sheet and internal budget are processed through PI’s Department at Emory to OSP

13. Subcontract Process – Emory and Children’s con’t • OSP contacts Children’s (Beverly Yandell) to begin subcontract process • Beverly Yandell: • Obtains Legal and Risk Management Department review • Resolves issues with Emory • Obtains signature from Children’s Institution Official and Emory • Provides original signed contract to Children’s Legal Department • Provides copy to PI, Coordinator and Finance Dept. • Opens Grant Activity account with Children’s Finance Dept. • Provides the NOTICE OF GRANT AWARD to PI and Finance Dept.

14. Review attached Routing Sheet Budget Approval for CHOA Subcontracts

15. Review attached NOTICE OF AWARD

16. Children’s Final Approval Process • ALL projects must have administrative approval of the Director of Clinical Research at Children’s • This is not an Institutional Review Board issue, the IRB process is independent from the Grants Accounting and Contracts process • This approval insures that pre-award processes have been completed

17. Approval Process for Children’s Projects • Submit the following to the Office of Grants Accounting and Contracts • Feasibility Assessment and Ancillary Dept Approval Form (signed by each Children’s Department being utilized) • IRB Approval Letter from CHOA • Patient Care Budget has to be on file in Grants Accounting office • Fully executed contract has to be on file in Grants Accounting office • Grant Activity account has been activated • Notice of Award has been completed

18. Approval Process for Emory Projects • Submit the following to the Office of Grants Accounting and Contracts: • One complete copy of Emory IRB submission with Approval Letter and approved informed consent • Completed Children’s Research Approval Form • Approved patient care budget must be on file in our office • Fully executed subcontract with Emory must be on file in our office • Children’s grant activity account has been activated (if needed) • Notice of Award has been provided to PI and/or Coordinator • Director will sign Research Approval Form and return to you

19. Review attached Research Approval Form

20. Post-Award Process

21. Coordinating the Project • Pre-Award process is complete • Grants Accounting and Contracts Office: • Creates necessary billing account within Children’s Patient Accounting system • Generates request forms for ancillary services • Facilitates study setup with each ancillary service (see attached example) • Sets up study on Children’s Website for patient pre-registration • Sets up our office internal billing system • If study is performed on both campuses, separate accounts are necessary • Coordinator meets with office staff to coordinate each project

22. Patient Care Invoicing • Most important issue of research patient care procedures is insuring that the patient and/or their insurance is not billed • Grants Accounting office has to know when these procedures are being performed, there is no internal “trigger” that alerts our office that a research patient has been seen at either hospital. • Charges are posted to the patient account by multiple people throughout the hospital. • Grants Accounting has to monitor all accounts and move charges • Requires a three step process to move a single charge • Grants Accounting has FIVE DAYS to move charges. If we haven’t moved them in five days the patient or their insurance will be billed • It is the coordinators job to insure that we have the information via: • Pre-registration process or • Notification of appointment date from coordinator if not pre-registered • Patient Trackers – see attached

23. Patient Care Invoicing – con’t • Grants Accounting internally tracts these charges for each study and generates an invoice to the coordinator • Coordinator approves and processes for payment • Invoices for Emory projects are processed through Emory for payment. Emory writes a check and mails to Grants Accounting office, our office processes check through Children’s Finance Dept. • Invoices for Children’s projects are processed internally. Coordinator returns approved invoice to our office and we internally charge the study grant activity account • Our office internally tracks dollars paid for research services and dollars applied to the research discount • Has to be balanced and reported to the Finance Dept at year end

24. Grants Accounting at Children’s • Grant Activity is created as part of the pre-award process • Costs of conducting the project are expensed to the activity • Coordinator or Research Manager processes paperwork for expenses through Grants Accounting either for approval or tracking purposes • Patient care costs – expensed to activity after coordinator approval • Salary Expenses – salary expenses reclassed from ‘operating budget’ to grant activity. Done by either Research Manager or Beverly Yandell • All other expenses (Purchase Orders, check requests, reimbursement request, etc.) • Only Managers and above can approve expenses for payment at Children’s • Grants Accounting insures that expense is allowable • Federal • Internal Foundation (Dudley Moore or Friends) • External Foundation • Private Industry

25. Grants Accounting at Children’s – con’t • Payment from sponsor is received by Grants Accounting office and processed to Finance Dept for deposit to the grant activity • Process for receiving dollars: • Sponsor pays as work is completed and received • Children’s invoices sponsor • Children’s invoices Emory for all subcontracts • Direct Costs deposited to Grant Activity Account • Indirect Costs deposited to Research Dept. • Monthly reports received from Finance Dept., Grants Accounting reviews for accuracy then forwards to either the PI or Research Manager • After completion of study & all expenses have been paid grant activity is closed

26. Grants Accounting at Emory • Emory administered grants are managed at the Emory Departmental level (primarily Dept of Pediatrics) • Children’s subcontracts with Emory are included as “Direct Costs” in Emory budgets • Children’s creates a grant activity for these subcontracts • Children’s processes expenses to the Children’s grant activity • Children’s invoices Emory Department for expenses posted to the Children’s grant activity • Children’s Grants Accounting collaborates with either the coordinator or the Research Manager to create the invoice • Checks are received in Children’s Grants Accounting and processed as revenue to the grant activity

27. Questions or Comments